What is Bioresearch Monitoring?
FDA’s Bioresearch Monitoring (BIMO) program is a comprehensive program of on-site inspections and data audits designed to monitor all aspects of the conduct and reporting of FDA regulated research.
What are Bimo listings?
The part II of the OSI request is to submit subject-level data listings by site (“BIMO listings”) for all major trials used to support safety and efficacy in the application. The requested BIMO listings for the most part is standard from one application to the other.
What does Bimo stand for?
BIMO
| Acronym | Definition |
|---|---|
| BIMO | Benign Idiopathic Macro-Orchidism |
Why was Bimo created?
The BIMO Program was established to assure the quality and integrity of data submitted to the agency in support of new product approvals, as well as, to provide for protection of the rights and welfare of the thousands of human subjects involved in FDA regulated research.
What do Bimo inspections cover?
A BIMO inspection has three purposes: to ensure human research participants’ rights, welfare, and safety, to determine the trial data’s accuracy and reliability, and to check for FDA regulatory compliance.
How long do you have to respond to a 483?
within 15 business days
When you receive an FDA Form 483, you must respond within 15 business days. However, to make sure that your response is timely, it’s best to respond within 15 calendar days. That shows the Agency that you are being proactive and that you are taking the observations seriously.
What are the metrics based on the center final classification?
• Metrics are based on the Center final classification determined in fiscal year (FY) 2020. COVID-19 Pandemic Due to the COVID-19 pandemic, FDA paused on-site surveillance inspections in March 2020 to protect the safety of our staff and stakeholders. During this timeframe we only
Who conducted the CDER bioequivalence inspections?
A portion of the CDER bioequivalence inspections were conducted independently by CDER subject matterexperts. • Metrics are based on the Center final classification determined in fiscal year (FY) 2020. COVID-19 Pandemic
What are the Inspectional data for the bimo program?
The inspectional data cover all aspects of FDA’s BIMO program (i.e., clinical investigators, IRBs, sponsors, bioequivalence, and good laboratory practices) for all Centers, as applicable.